Description

My client, a top 15 pharmaceutical company based in Essex is currently searching for a Regulatory Affairs Manager to join their team and oversee a regulatory officer. If you have a strong background in European Regulatory Affairs and enjoy working in a varied and fast-paced environment, this role could be a great fit for you.

The focus of the role will be on the submission of new generic Marketing Authorisation Applications for a wide variety of products and dosage forms for Retail use registered via the Decentralised or Mutual Recognition Procedures.

You will primarily work with third party partners, specifically on European projects and be responsible for reviewing the technical content of third party dossiers against EU regulatory requirements for generic products. In addition you will prepare and submit high quality regulatory dossiers and post marketing documentation.

Skills & Experience

To be considered for this role you will have the below skills and experience:
Degree (or equivalent) in a Life Sciences or Pharmacy related subject
Substantial industrial experience within Regulatory Affairs including practical experience of European submission procedures
A good understanding of European regulatory requirements and guidelines for generic products.
Previous CMC experience (or a demonstrated technical aptitude) and familiarity with the scientific content of the dossier
Previous supervisory or mentoring experience would be an advantage

Main Responsibilities

Review the technical content of third party dossiers as part of the in-licensing decision making process
Work closely with third party partners in order to prepare and submit high quality regulatory dossiers including Marketing Authorisation Applications, response to Health Authority questions and critical pre-launch post-approval variations
Be able to understand complex issues and clearly communicate issues to customer base
Represent team during strategic and technical discussions, including participating in project teams
Enjoy the challenge of working under pressure whilst consistently ensuring that internal and external deadlines are met
Line management of a Regulatory Affairs Associate

For further details about this role, please contact Tim Barratt on +44(0)1727 817 626 or email tbarratt@keypeople.co.uk

Company Name:

Key People

Headquarters:

Catherine House,Adelaide Street

Sector:

Staffing Firms

Country:

United Kingdom

Zipcode:

AL3 5BA

Website:

www.keypeople.co.uk

Employees:

less than 100

Industry:

Pharmaceutical

City:

St Albans

Phone No. :

01727 817 626

Key People is a recognised leading supplier of staffing and recruitment services to the Pharmaceutical, Scientific & Biotech industry. The company has been operating for over 20 years and has an integrated team of qualified recruitment consultants averaging more than 7 years of recruitment experience. Each consultant is a specialist recruiter for their market area, so they can provide full market advice to candidates and clients alike.